Synbiotics in Advanced HIV Infection

HIV Infection Asymptomatic Clinical Trial

— PROMALTIA  

Official title:

Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009032
• Other study ID #: 14/016
• Status: Completed
• Phase: N/A
• First received: December 28, 2016
• Last updated: July 30, 2017
• Start date: February 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS

• Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines

Exclusion Criteria:

• Age <18 years

• Pregnancy

• Type 1 or 2 diabetes

• End-stage renal disease

• Lactose intolerance

• Use of immunomodulatory drugs

• Neutrophil count <750cells/uL

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection Asymptomatic
• HIV Infections
• Infection

Intervention

Dietary Supplement:
• PMT25341

• Placebo
Lactose

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Hospital del Mar, Hospital San Carlos, Madrid, Hospital San Pedro, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		From baseline through week 48
Primary	Changes in CD4+ T cell counts/uL		From baseline through week 48
Primary	Changes in CD8+ T cell counts/uL		From baseline through week 48
Primary	Changes in CD4/CD8 ratio		From baseline through week 48
Secondary	Microbiota composition: alpha-diversity		From baseline through week 48
Secondary	Microbiota composition: Unifrac distances		From baseline through week 48
Secondary	Microbiota composition: Canberra distances		From baseline through week 48
Secondary	Changes in plasma soluble CD14 levels		From baseline through week 48
Secondary	Changes in plasma hs-CRP levels		From baseline through week 48
Secondary	Changes in plasma IFABP levels		From baseline through week 48
Secondary	Changes in plasma lipoteichoic acid levels		From baseline through week 48
Secondary	Changes in plasma kynurenine/tryptophan ratio		From baseline through week 48
Secondary	Changes in percentage of HLADR+/CD38+ T cells		From baseline through week 48